With the standard Quality Issue object, users can track, manage, and report on quality issues via a user action on document lifecycle states.
Note: This feature is only available on Clinical Operations eTMF and Clinical Operations Study Startup Vaults.
Configuration Overview
- Add the # of Open Issues, # of Closed Issues, and # of Total Issues document fields to document types that need quality issue tracking.
- Add the Create Related Record user action to document lifecycle states where you want quality issues available. Enter an Action Label and select Quality Issue as the Object, and Related Document as the Field to Default.
- Add Read permission for the Quality Issues object on relevant permission sets.
- Optional: Set the Enable Quality Issue Related Document Deletion setting to true to make the Related Document field optional. If selected, when users delete a document that is referenced by a Quality Issue, Vault allows the deletion and updates the Related Document field to be blank on the Quality Issue.
- Optional: Adjust the Default Value for the Due Date field on the Quality Issue object.
- Optional: Secure the Study and Blinding fields.
Note: The Enable Quality Issue Related Document Deletion setting is enabled by a one way flag that cannot be reverted. In other words, if you enable the setting, you can not disable it at a later time.
Securing the Study & Content Fields
You can enable study and blinding security to automatically populate the Study and Content (blinding__v) fields on Quality Issues.
- Navigate to Admin > Settings > Application Settings > Edit. Set the Enable Study and Blinding Security on Quality Issues checkbox and click Save.
- Add the Securing Study and Securing Content fields to the Quality Issue page layout.
- If there are existing Study and Content fields, remove them from the Quality Issue page layout.
Note: You must create Quality Issues from the Document in order for Vault to automatically update these fields.
Once enabled, you can configure Dynamic Access Control for the Study and Content fields.
Note: Adding field level security to the Study field may prevent users from resolving Quality Issue tasks.